Health Care UtilizationNCT04652154
Transitioning Young Patients' Health Care Trajectories
A study testing Transitioning young patients' health care trajectories in people with Health Care Utilization and Mental Health Impairment, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The project aims to transition the approach used to care for children with complex conditions and care pathways into a more holistic and coordinated model. The traditional model where specialists independently treat single diseases, makes joint and coordinated decisions about patients with multiple and unclear… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Health Care Utilization, Mental Health Impairment, Child, Only
- What is being tested?
- Transitioning young patients' health care trajectories
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2020to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-16 years,
- Previous referred to specialist health care service for 3 or more times, including mental health service as well paediatric service.
Who cannot join
- Not within age range
- Less than 3 referrals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transitioning Young Patients' Health Care Trajectories (TpT) Bridging the Gap Between Mental and Somatic Health Services "Tjenester på Tvers"
The project aims to transition the approach used to care for children with complex conditions and care pathways into a more holistic and coordinated model. The traditional model where specialists independently treat single diseases, makes joint and coordinated decisions about patients with multiple and unclear conditions difficult. In particular there is a gap between mental and somatic services.
In preparation for re-designing the care model, several pre-studies are conducted, both a register study and a collection of user reported experiences. Built on the results, we have invented multi-disciplinary teams of complementary competences including paediatricians, psychologists, and physiotherapists to meet the patient and family. The study includes:
- To implement the new team intervention in a clinical case-control study
- To scientifically evaluate the intervention
- To systematise lessons learned in regard to potential spread across systems and patient groups Children 6-16 years together with family and professionals will constitute the team. The assessment aims to clarify the patient's condition through shared decision making and to develop a treatment plan for the child. It is a clinical randomised controlled trial where TpT children will be compared to children following treatment as usual. It includes a one year follow-up regarding a set of evaluation domains: provider perspectives, user-centred experiences and outcomes, as well as health care outcomes.
Read the detailed description
200 children with multi-referrals will be invited to either intervention or treatment as usual at their third or more referral to Haukeland university hospital.
In the intervention group the child and family will meet a complementary team of professionals for more than two hours aimimg to get a clarification of the patient's condition and giving coping strategies for their condition. Outcome defined as better mental health and quality of life as well as increased school attendence are some of the measures being collected. These outcomes will be compared to the control group after 12 mth.
- Being tested
- Transitioning young patients' health care trajectories
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitioning young patients' health care trajectoriesOther
New intervention where the patient with multi-referrals to specialist health service meet with a complementary professional team consisting of doctor, psychologist and physioterapist aiming clarify the child's condition through shared decison-making and agreeing upon treatment plans for the child
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Control group is recieving treatment as ususal Receives: Other: Transitioning young patients' health care trajectories |
| Intervention group | Experimental | The intervention group getting the new assessment by a complementary professional team Receives: Other: Transitioning young patients' health care trajectories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contentment with the intervention - Patient
Patient evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Patient)" with two items and for each item has a score 1-4 and 4 is most positive.
Measured: Through study completion, an average of 2 years
Contentment with the intervention - Parents
Parents evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Parent)" with two items and score for each item has 1-4 and 4 is most positive.
Measured: Baseline
Contentment with the intervention - Parents
Parents evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Parent)" with two items and score for each item has 1-4 and 4 is most positive.
Measured: Through study completion, an average of 2 years
Contentment with the intervention - Professionals
Professionals evaluate the intervention - A questionnaire for the study has been developed Usefulness of the TpT intervention with two items and score for each item has 1-4 and 4 is most positive.
Measured: Through study completion, an average of 2 years
Mental health status
Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems.
Measured: Baseline
Mental health status
Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems.
Measured: 1 year after the intervention
Mental health status
Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems.
Measured: 2 year after the intervention
Quality of Life: KIDSCREEN-27 Barne/ungdomsversjon 8-18år
Using KIDSCREEN-27 to evaluate Quality of Life, caregiver provide information in five dimensions these are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy \& Parents (7 items), Peers \& Social Support (4 items), and School Environment (4 items).
Each item has a scale of five where 1 is "not at all" is worse outcome and 5 "very much" is the best outcome.
Measured: Baseline
Quality of Life: KIDSCREEN-10 Barne/ungdomsversjon 8-18år
Using KIDSCREEN-10 to evaluate Quality of Life, caregiver provide information in five dimensions these are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy \& Parents (7 items), Peers \& Social Support (4 items), and School Environment (4 items).
Each item has a scale of five where 1 is "not at all" is worse outcome and 5 "very much" is the best outcome.
Measured: 1 year after the intervention
Secondary outcomes (1)
Contact with specialist healthcare
Post evaluation of use of health services - numbers of new referrals
Measured: 1 year after the intervention after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Feb 2020
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are invited to either intervention or treatment as usual
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Hans Olav Instefjord, Master, Study chair, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652154
- Sponsor's protocol ID
- 2018/344
- Status last verified
- Feb 2023
- First submitted
- 31 Oct 2020
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elgen I, Lygre RB, Arli A, Heggestad T. An interdisciplinary intervention for children with complex health complaints; a feasibility study of selection criteria. Front Pediatr. 2023 Sep 14;11:1167528. doi: 10.3389/fped.2023.1167528. eCollection 2023.
PubMed 37780046Elgen I, Heggestad T, Tronstad R, Greve G. Bridging the Gap for Children With Compound Health Challenges: An Intervention Protocol. Front Pediatr. 2021 Dec 22;9:721926. doi: 10.3389/fped.2021.721926. eCollection 2021.
PubMed 35004532Heggestad T, Greve G, Skilbrei B, Elgen I. Complex care pathways for children with multiple referrals demonstrated in a retrospective population-based study. Acta Paediatr. 2020 Dec;109(12):2641-2647. doi: 10.1111/apa.15250. Epub 2020 Apr 17.
PubMed 32159873Elgen I, Lygre R, Greve G, Griffiths S, Heggestad T. Interdisciplinary Approaches Suggested for Children With Multiple Hospital Referrals Presenting With Non-specific Conditions. Front Pediatr. 2021 Apr 7;9:656939. doi: 10.3389/fped.2021.656939. eCollection 2021.
PubMed 33898364Lygre RB, Gjestad R, Norekval TM, Mercer SW, Elgen IB. An interdisciplinary intervention for children and adolescents with multiple referrals and complex health complaints: a feasibility study. BMC Health Serv Res. 2023 Nov 11;23(1):1241. doi: 10.1186/s12913-023-10250-y.
PubMed 37951903Lygre RB, Thuen VM, Gjestad R, Norekval TM, Greve G, Mildestvedt T, Elgen IB. How can we improve specialist health services for children with multi-referrals? Parent reported experience. BMC Health Serv Res. 2020 Aug 24;20(1):786. doi: 10.1186/s12913-020-05666-9.
PubMed 32831078
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitioning Young Patients' Health Care Trajectories (TpT) Bridging the Gap Between Mental and Somatic Health Services "Tjenester på Tvers"
- ClinicalTrials.gov ID
- NCT04652154
- Acronym / sponsor ID
- 2018/344
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project aims to transition the approach used to care for children with complex conditions and care pathways into a more holistic and coordinated model. The traditional model where specialists independently treat single diseases, makes joint and coordinated decisions about patients with multiple and unclear conditions difficult. In particular there is a gap between mental and somatic services.
In preparation for re-designing the care model, several pre-studies are conducted, both a register study and a collection of user reported experiences. Built on the results, we have invented multi-disciplinary teams of complementary competences including paediatricians, psychologists, and physiotherapists to meet the patient and family. The study includes:
- To implement the new team intervention in a clinical case-control study
- To scientifically evaluate the intervention
- To systematise lessons learned in regard to potential spread across systems and patient groups Children 6-16 years together with family and professionals will constitute the team. The assessment aims to clarify the patient's condition through shared decision making and to develop a treatment plan for the child. It is a clinical randomised controlled trial where TpT children will be compared to children following treatment as usual. It includes a one year follow-up regarding a set of evaluation domains: provider perspectives, user-centred experiences and outcomes, as well as health care outcomes.
Detailed description
200 children with multi-referrals will be invited to either intervention or treatment as usual at their third or more referral to Haukeland university hospital.
In the intervention group the child and family will meet a complementary team of professionals for more than two hours aimimg to get a clarification of the patient's condition and giving coping strategies for their condition. Outcome defined as better mental health and quality of life as well as increased school attendence are some of the measures being collected. These outcomes will be compared to the control group after 12 mth.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are invited to either intervention or treatment as usual
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Transitioning young patients' health care trajectoriesControl group is recieving treatment as ususal |
| Intervention group | Experimental | Other: Transitioning young patients' health care trajectoriesThe intervention group getting the new assessment by a complementary professional team |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 6-16 years,
- Previous referred to specialist health care service for 3 or more times, including mental health service as well paediatric service.
Key exclusion criteria (2 listed)
- Not within age range
- Less than 3 referrals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transitioning young patients' health care trajectoriesNew intervention where the patient with multi-referrals to specialist health service meet with a complementary professional team consisting of doctor, psychologist and physioterapist aiming clarify the child's condition through shared decison-making and agreeing upon treatment plans for the child | Other | Control, Intervention group |
Primary outcome
Contentment with the intervention - Patient
Time frame: Through study completion, an average of 2 years
Patient evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Patient)" with two items and for each item has a score 1-4 and 4 is most positive.
Contentment with the intervention - Parents
Time frame: Baseline
Parents evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Parent)" with two items and score for each item has 1-4 and 4 is most positive.
Contentment with the intervention - Parents
Time frame: Through study completion, an average of 2 years
Parents evaluate the intervention - A questionnaire for the study has been developed "Contentment of the TpT intervention (Parent)" with two items and score for each item has 1-4 and 4 is most positive.
Contentment with the intervention - Professionals
Time frame: Through study completion, an average of 2 years
Professionals evaluate the intervention - A questionnaire for the study has been developed Usefulness of the TpT intervention with two items and score for each item has 1-4 and 4 is most positive.
Mental health status
Time frame: Baseline
Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems.
Mental health status
Time frame: 1 year after the intervention
Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems.
Mental health status
Time frame: 2 year after the intervention
Strenght and Difficulty Questionnaire (SDQ) is a mental health screening questionnaire. It constitutes 20 items, with five items in each of the four subscales:emotional problems, hyperactivity/inattention, conduct problems, and peer problems.
Quality of Life: KIDSCREEN-27 Barne/ungdomsversjon 8-18år
Time frame: Baseline
Using KIDSCREEN-27 to evaluate Quality of Life, caregiver provide information in five dimensions these are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy \& Parents (7 items), Peers \& Social Support (4 items), and School Environment (4 items). Each item has a scale of five where 1 is "not at all" is worse outcome and 5 "very much" is the best outcome.
Quality of Life: KIDSCREEN-10 Barne/ungdomsversjon 8-18år
Time frame: 1 year after the intervention
Using KIDSCREEN-10 to evaluate Quality of Life, caregiver provide information in five dimensions these are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy \& Parents (7 items), Peers \& Social Support (4 items), and School Environment (4 items). Each item has a scale of five where 1 is "not at all" is worse outcome and 5 "very much" is the best outcome.
1 secondary outcome
Contact with specialist healthcare
Time frame: 1 year after the intervention after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Results publication: PubMed 37780046Elgen I, Lygre RB, Arli A, Heggestad T. An interdisciplinary intervention for children with complex health complaints; a feasibility study of selection criteria. Front Pediatr. 2023 Sep 14;11:1167528. doi: 10.3389/fped.2023.1167528. eCollection 2023.
- Results publication: PubMed 35004532Elgen I, Heggestad T, Tronstad R, Greve G. Bridging the Gap for Children With Compound Health Challenges: An Intervention Protocol. Front Pediatr. 2021 Dec 22;9:721926. doi: 10.3389/fped.2021.721926. eCollection 2021.
- Results publication: PubMed 32159873Heggestad T, Greve G, Skilbrei B, Elgen I. Complex care pathways for children with multiple referrals demonstrated in a retrospective population-based study. Acta Paediatr. 2020 Dec;109(12):2641-2647. doi: 10.1111/apa.15250. Epub 2020 Apr 17.
- Results publication: PubMed 33898364Elgen I, Lygre R, Greve G, Griffiths S, Heggestad T. Interdisciplinary Approaches Suggested for Children With Multiple Hospital Referrals Presenting With Non-specific Conditions. Front Pediatr. 2021 Apr 7;9:656939. doi: 10.3389/fped.2021.656939. eCollection 2021.
- Results publication: PubMed 37951903Lygre RB, Gjestad R, Norekval TM, Mercer SW, Elgen IB. An interdisciplinary intervention for children and adolescents with multiple referrals and complex health complaints: a feasibility study. BMC Health Serv Res. 2023 Nov 11;23(1):1241. doi: 10.1186/s12913-023-10250-y.
- Results publication: PubMed 32831078Lygre RB, Thuen VM, Gjestad R, Norekval TM, Greve G, Mildestvedt T, Elgen IB. How can we improve specialist health services for children with multi-referrals? Parent reported experience. BMC Health Serv Res. 2020 Aug 24;20(1):786. doi: 10.1186/s12913-020-05666-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Olav Instefjord, Master study chair
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitioning young patients' health care trajectories in people with Health Care Utilization and Mental Health Impairment, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contentment with the intervention - Patient (time frame: Through study completion, an average of 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04652154, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.